A Study to Evaluate 90-Day Safety of Tapentadol(CG5503) Immediate Release (IR) or Oxycodone Immediate Release in Patients With Chronic Pain

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety of CG5503 base Immediate Release(IR) 50 mg or 100 mg taken every 4 to 6 hours as needed over the long-term exposure of 90 days in patients who have chronic pain.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: Grünenthal GmbH
• Treatments: Oxycodone; Tapentadol

Criteria

Inclusion Criteria:

• A clinical diagnosis of one of the following: low-back pain of non-malignant origin for at least 3 months, osteoarthritis of the knee or hip for at least 3 months

• require daily doses of analgesia medication for chronic pain that is consistent with or makes them candidates for treatment at Step 2 or higher of the WHO Pain Relief Ladder

• post-washout baseline pain intensity score >4 on an 11-point numerical rating scale

Exclusion Criteria:

• History of seizure disorder or epilepsy

• uncontrolled hypertension

• currently treated with monoamine oxidase inhibitors

• systemic steroid therapy, excluding inhalers or topical steroids, within 3 months before screening

• history of malignancy within the past 2 years, with the exception of basal cell carcinoma